Chronic Kidney Disease and Non-alcoholic Fatty Liver Diseases

NCT ID: NCT04779905

Last Updated: 2021-11-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-28
• Study Completion Date: 2021-09-15

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease worldwide. This disease reportedly affects up to 30% of the general population in Western countries, especially in patients with metabolic syndrome, obesity, and type II diabetes. NAFLD is considered to be an independent risk factor for cardiovascular disease and there is accumulating evidence to support a causative role in the development of chronic kidney disease (CKD). So, we aim first to assess the prevalence of chronic kidney disease in NAFLD patients, secondly to detect the association between hepatic fibrosis and CKD in NAFLD patients

Detailed Description

This study will be conducted on 100 patients 70 patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital, and A control group of 30 healthy volunteers who looks normal on ultrasonography from February 2021 to July 2021.

Methods:

All included patients will be subjected to:

1. Detailed history, complete general and systemic examination .

2. BMI will be calculated as follow

3. Abdominal Ultrasonography.

4. Laboratory investigations:

Fasting and post-prandial blood sugar Serum lipogram. Liver function tests. Serum creatinine, Albumin -creatinine Ratio.

5. Calculation of estimated Glomerular Filtration Rate eGFR.

6. Liver stiffness measurements to detect degree of fibrosis and measurement of the degree of steatosis using (Fibroscan)

Ethical considerations:

The study will be approved by The Ethical committee of Sohag Faculty of Medicine, Sohag University.

The study protocol will be adherent to practice guidelines of the World Medical Association Code of Ethics (Declaration of Helsinki).

After explanation about the nature of the procedures, possible complications, benefits, and steps of the study, All patients will give a written informed consent for participating in the study, performing abdominal ultrasound, taking blood samples, performing fibroscan.

Conditions

Chronic Kidney Diseases; NAFLD

Keywords

chronic kidney disease; NAFLD; Hepatic fibrosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Non-alcoholic Fatty Liver Diseases

patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital

urinary albumbin/creatinine ratio

Intervention Type: DIAGNOSTIC_TEST

detection of microalbuminuria in nafld patients

control

healthy volunteers who looks normal on ultrasonography

urinary albumbin/creatinine ratio

Intervention Type: DIAGNOSTIC_TEST

detection of microalbuminuria in nafld patients

Interventions

urinary albumbin/creatinine ratio

detection of microalbuminuria in nafld patients

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

estimated glomerular filtration rate

Eligibility Criteria

Inclusion Criteria

patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital

Exclusion Criteria

1. Diabetic patients.

2. Hypertensive patients.

3. Other causes of chronic liver disease rather than NAFLD.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mona Mohammed Abdelrhman

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Radwa Farag, MD

Role: STUDY_CHAIR

Sohag University

Mohamed Amin, MD

Role: STUDY_CHAIR

Sohag University

Shimaa Hemdan, MD

Role: STUDY_CHAIR

Sohag University

Locations

Mona Mohammed Abdelrahman

Sohag, , Egypt

Countries

Egypt

References

Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011 Aug;34(3):274-85. doi: 10.1111/j.1365-2036.2011.04724.x. Epub 2011 May 30.

Reference Type: BACKGROUND

PMID: 21623852 (View on PubMed)

Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available.

Reference Type: BACKGROUND

PMID: 22488764 (View on PubMed)

Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.

Reference Type: BACKGROUND

PMID: 24042449 (View on PubMed)

McCullough K, Sharma P, Ali T, Khan I, Smith WC, MacLeod A, Black C. Measuring the population burden of chronic kidney disease: a systematic literature review of the estimated prevalence of impaired kidney function. Nephrol Dial Transplant. 2012 May;27(5):1812-21. doi: 10.1093/ndt/gfr547. Epub 2011 Sep 29.

Reference Type: BACKGROUND

PMID: 21965592 (View on PubMed)

Other Identifiers

Soh-Med-21-02-40

Identifier Type: -

Identifier Source: org_study_id